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Tamima Itani, Ph.D., RAC, FRAPS is currently Vice President, Global Regulatory Affairs and Global Regulatory Compliance, at Boston Scientific Corporation.Previously, she was VP, Global Regulatory Affairs, Medication Delivery, Baxter; VP, Clinical and Regulatory Affairs, ev3, Inc., Minneapolis, MN, and VP, Quality Systems and Regulatory Affairs, Ethicon Endo-Surgery, Inc., a Johnson & Johnson company. Her responsibilities have included strategic regulatory, clinical and quality systems leadership for a broad range of class II and class III medical devices, pharmaceutical products and combination products. She is active on AdvaMed and MDMA working groups, is a member of RAPS, was the MDMA industry representative to the MDUFA III negotiations with FDA, and is currently the MDMA industry representative to the MDUFA IV negotiations.Dr. Itani holds a Bachelor of Science degree in Electrical Engineering from the American University of Beirut and Master of Science and Ph.D. degrees in Biomedical Engineering from Northwestern University, Evanston, IL.